Regulatory Knowledge and Suppport Program

Ensuring that the more than 1,000 clinical research studies that open annually across our hub are compliant, efficient and safe, requires comprehensive regulatory tools and consultative services. The Regulatory Knowledge and Support Program (RKS) provides investigators with expert regulatory guidance and advice to facilitate clinical and translational research in conformance with Institutional Review Board (IRB) policies, state laws and federal regulations.

Services & Tools

Coordination Services & Education (CSE) and Study Activation

Dedicated teams can assist with the regulatory, financial and compliance-related components of clinical research during study activation, conduct and closeout of a clinical trial--and provide study team training and education.

CTSI Office of Regulatory Affairs

Assists with Data and Safety Monitoring Board, internal monitoring and auditing, prep for FDA/sponsor inspection, guidance on clinicaltrials.gov registration and results reporting, and scientific review

Consults on Research Ethics

Confidential consults in research ethics to all members of research teams on study design, execution, reporting and more.

Program Aim

Provide tools and support to facilitate compliant clinical and translational research.

Provide tools and support to facilitate creation of high-quality protocols.
Implement and optimize regulatory workflows with the use of electronic regulatory binders and DocuSign integration.
Develop an FDA IND/IDE knowledge hub, pre-IND regulatory support services, and support for FDA issues regarding mHealth and emergent digital health technologies.
Adapt regulatory and ethics training and consults for community-based research.

Contact Us

For RKS questions, please contact the below personnel:

General Questions
Terra Hughes
Director, CTSI Office of Regulatory Affairs
TNHughes@mednet.ucla.edu

CTSI Coordination Services & Education (CSE) and Study Activation
studyactivation@mednet.ucla.edu

CTSI Office of Regulatory Affairs
ctsiora@mednet.ucla.edu

Confidential Consults in Research Ethics
Dr. Stanley Korenman, skorenman@mednet.ucla.edu.